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Mild renal insufficiency and forearm blood flow.


- candidate number2834
- NTR NumberNTR1104
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-okt-2007
- Secondary IDs2605 
- Public TitleMild renal insufficiency and forearm blood flow.
- Scientific TitleSystemic effects of mild renal insufficiency: the relation between forearm blood flow and ADMA.
- ACRONYMN/A
- hypothesisThe ADMA-level in hypertensive subjects will be reversely related to the basal blood flow and the endothelial NO-availability in the forearm. Pre-treatment with an angiotensin-II- receptorblocker and/or a statin will decrease the ADMA-levels via increased clearance of ADMA and, consequently, will ‘normalise’ the forearm blood flow and NO-availability.
- Healt Condition(s) or Problem(s) studiedHypertension, Mild renal insufficiency
- Inclusion criteria1. Hypertension (without medication blood pressure >140/90 mmHg and <180/110 mmHg);
2. creatinine clearance 60-90 ml/min;
3. microalbuminuria (30-300 mg albumin/24 hours);
4. age 18-75 years;
5. BMI between 18 and 30 kg/m2.
- Exclusion criteria1. Diabetes mellitus;
2. contra-indication for use of an angiontensin-II-receptorblocker or statin.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2007
- planned closingdate1-nov-2008
- Target number of participants60
- InterventionsThe patients will be treated with eprosartan 600 mg and/or rosuvastatin 20 mg during a three-weeks interval.
- Primary outcomeForearm blood flow (FBF).
- Secondary outcomeADMA (asymmetric dimethylarginine) concentration in the blood.
- TimepointsBaseline forearm blood flow measurement (without medication) at t=0. Second forearm blood flow measurement 3 weeks later.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdr. A.A. Kroon
- CONTACT for SCIENTIFIC QUERIESdr. A.A. Kroon
- Sponsor/Initiator Academic Hospital Maastricht (AZM)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Heart Foundation (Nederlandse Hartstichting)
- PublicationsN/A
- Brief summaryIn this study the relationship between the systemic NO-mediated endothelium-dependant vasodilatation, measured as forearm blood flow and venous ADMA-level is studied, in hypertensive as well as healthy subjects. In the hypertensive subjects it also will be examined to what extend the forearm blood flow (FBF) can be influenced by treatment with an angiotensin-II- receptorblocker (eprosartan) and/or a statin (rosuvastatin).
- Main changes (audit trail)
- RECORD24-okt-2007 - 25-mrt-2008


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